Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.

NCT04819568 | Unknown

• 1 other identifier: ILBS-Cirrhosis-39
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Septic shock is a major life-threatening vasodilatory shock. Vasopressor form a crucial pharmacotherapeutic option and have long been used as the first and foremost recommended therapy.(1) However, some patients may remain refractory to catecholamine, which is also known as catecholamine-resistant septic shock.(2, 3) High-dose catecholamine therapy may lead to potential side effects such as increased myocardial oxygen consumption, lethal arrthymias, and even the high risk of mortality. (4)Therefore, newer alternatives like dopamine, dobutamine, somatostatin, and terlipressin are also used. Cirrhosis is a state of hyperdynamic circulation, which worsens with the onset of infection. In septic shock, there is relative deficiency of vasopressin. (13) The mortality of septic shock in these patients still remains extremely high. Terlipressin is a synthetic vasopressin analogue with greater selectivity for the V1-receptors.(5) In cirrhotics with septic shock, terlipressin has been used either as a continuous intravenous infusion or as intravenous boluses. However, at present none of studies reveal which would be a better mode of administration in cirrhotics with septic shock considering the reversal of hemodynamics and safety of patients.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Reversal of shock

  DISCONTINUATION OF NOREPINEPHRINE IS CONSIDERED AS REVERSAL OF SHOCK.

  72 hours

Secondary Outcomes (15)

• Time to reversal of shock

  1 Year

• Incidence of adverse effects and discontinuation of therapy due to adverse effects

  24 hours

• Incidence of adverse effects and discontinuation of therapy due to adverse effects

  Day 3

• Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT)

  24 hours

• Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT)

  Day 3

Study Arms (2)

Terlipressin Bolus Arm

EXPERIMENTAL

Drug: Terlipressin; Other: Standard of Care

Terlipressin Continuous Infusion Arm

ACTIVE COMPARATOR

Drug: Terlipressin; Other: Standard of Care

Interventions

Terlipressin DRUG

Terlipressin Bolus Max dose 2 mg/24 hr.i.e 0.5 mg qid

Terlipressin Bolus Arm; Terlipressin Continuous Infusion Arm

Standard of Care OTHER

Standard of Care

Terlipressin Bolus Arm; Terlipressin Continuous Infusion Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Cirrhotics including ACLF with septic shock requiring norepinephrine dose \>0.5ug/kg/min to maintain MAP\> 65 mm Hg
• \- An informed consent from the patient or relative

You may not qualify if:

• Patients with age less than 18 years or more than 65 years
• Severe known cardiopulmonary disease (Hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias)
• Stroke
• Peripheral Vascular disease
• Gut Paralysis
• Intestinal obstruction
• Cancer, hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy
• Portal vein thrombosis
• Hepatic vein outflow tract obstruction (HVOTO )
• Pregnancy
• Patients with Pa02/FiO2 ratio \<150
• Severe coagulopathy platelets \<20,000 and INR \> 4
• Active Bleed (Mucosal or variceal)
• Patients already on terlipressin in the last 48 hours
• Extremely moribund patients with an expected life expectancy of less than 24 hours

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Terlipressin; Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dr Priti Gupta, MD

CONTACT

01146300000; priti7vns@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 29, 2021
• Study Start: June 25, 2021
• Primary Completion: March 19, 2022
• Study Completion: March 19, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-10

Locations

IN (1)